Z-0148-2007

AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses

Name: Z-0148-2007 AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
Creator: Advanced Medical Optics, Inc.
Published: 2006-11-29
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2006-11-29 / Terminated / root cause: labeling and UDI

FDA source

Advanced Medical Optics, Inc. began a recall of AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses on 2006-11-29. The reason FDA records is "The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0148-2007
Status: Terminated
Initiated: 2006-11-29
Posted: 2006-12-14
Terminated: 2011-05-24
Recalling firm: Advanced Medical Optics, Inc.
Product: AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
Product code: HQL Intraocular Lens
Reason for recall: The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On November 13, 2006, an 'URGENT MEDICAL DEVICE RECALL' letter was mailed to all affected US customers communicating their recall strategy regarding the removal of five (5) ZA9003 lenses in US distribution. This letter included in this correspondence is a listing of the serial numbers and the quantities of intraocular lenses shipped. This listing will act as your Facsimile Form to be returned to AMO for accountability of the lenses shipped to your facility. AMO will ensure the effectiveness of the recall by using a return facsimile form to capture the status of each of the lenses.
Quantity in commerce: 10 lenses
Distribution: Worldwide, including USA (CT, TX, NY), Canada, and UK.
Product codes and lots: Serial numbers: 531644065, 5316450605, 5316460605, 5316470605, 5316490605, 5316500605, and 5316510605

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)